Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks

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Pfizer

Status and phase

Completed
Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: CP-690,550
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00147498
A3921019

Details and patient eligibility

About

The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily [BID]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).

Enrollment

264 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The subject has a history of inadequate response to at least 1, but no more than 4, of the following DMARDs: sulfasalazine, injectable gold, methotrexate, leflunomide, cyclosporine, or a thiopurine derivative (azathioprine or 6-mercaptopurine)

Exclusion criteria

Current Therapy With Any DMARD Or Biologic

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

264 participants in 4 patient groups, including a placebo group

5 mg BID
Experimental group
Description:
CP 690,550 5 mg BID
Treatment:
Drug: CP-690,550
15 mg BID
Experimental group
Description:
CP 690,550 15 mg BID
Treatment:
Drug: CP-690,550
30 mg BID
Experimental group
Description:
Oral tablets administered at a dose of 30 mg BID for 6 weeks
Treatment:
Drug: CP-690,550
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Other: Placebo

Trial contacts and locations

60

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Data sourced from clinicaltrials.gov

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